The FDA has approved satralizumab for adults with thyroid eye disease, introducing the first at-home subcutaneous treatment option. The decision follows two Phase 3 trials, one of which missed its primary endpoint, while the other demonstrated significant improvements in eye bulging and double vision.
A peer-reviewed validation study found that patients with high OncoPrism-NSCLC scores had a 71% response rate to checkpoint inhibitor-based treatment, compared with 36% in lower-scoring groups. The analysis included 1,487 patients across four datasets, although the prospective clinical utility of using the test to choose treatment remains unproven.
Genentech's vamikibart sustained vision gains at 52 weeks, but mixed Phase III results leave questions ahead of a July 2027 FDA decision.
FDA approval moves Tecentriq into adjuvant stage III dMMR colon cancer after ATOMIC showed a 50% reduction in recurrence or death risk.
Genentech has entered a global collaboration with DualityBio to develop antibody-drug conjugates using novel payloads designed to address tumors resistant to widely used topoisomerase inhibitor ADCs.
Genentech has licensed HM17321 outside South Korea for $190 million upfront and up to about $2.3 billion in total potential payments, betting on a UCN2 mechanism designed to reduce fat while preserving lean mass.
Genentech will spend about $750 million to add end-to-end device fill-finish capabilities in Oregon, doubling its Hillsboro site and targeting commercial operations in 2031.
Genentech’s $2 billion Holly Springs plant reaches a key milestone as Roche builds U.S. manufacturing capacity for future metabolic medicines.
Roche’s Susvimo wins a positive European opinion for wet AMD. See how two yearly refills could reduce injections and reshape retinal care.
FDA Priority Review puts Genentech’s Gazyva on a November decision path in primary membranous nephropathy after the Phase III MAJESTY win.